the Gut Microbiome and Metabolomics in Chronic Lower extreMities Threatening Ischemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-15

Study Completion Date

2025-05-15

Brief Summary

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Intestinal floras and their metabolites are involved in progressing metabolic and cardiovascular diseases. However, currently, articles related to the relationship between intestinal floras and atherosclerosis mainly focus on coronary atherosclerotic disease (CAD) population, or atherosclerosis model animals such as ApoE-/-, LDLR-/- high-fat diet mice, and there are few studies on Chronic limb-threatening ischemia (CLTI). CLTI and CAD have a similar pathological basis of atherosclerosis. It is unclear whether intestinal flora plays an essential role in the occurrence and development of CLTI. This project aims to explore the relation between microorganisms, metabolites, and CLTI.

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Detailed Description

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This project aims to study the intestinal flora and its metabolites in patients with CLTI, explore whether CLTI patients and CAD patients have their own characteristic flora, analyze the microorganisms and metabolites markers of poor prognosis in patients with CLTI, and screen out the key differential bacteria and metabolites that inhibit the progress of CLTI, in order to provide new insights and research basis for the treatment of CLTI.

Conditions

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Chronic Limb-threatening Ischemia Microtia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic limb-threatening ischemia

Resting pain for at least 2 weeks with at least one hemodynamic index: ABI\<0.4,AP\<50mmHg, TP or TCPO2\<30mmHg. Tissue defects (ulceration or gangrene) persisted for at least 2 weeks with at least one significant PAD objective evidence: ABI\<0.8, AP\<100mmHg, TP or TCPO2\<60mmHg.

No interventions assigned to this group

health control

sex - and age-matched healthy people (without history of atherosclerotic plaque, coronary heart disease or stroke).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Control group: sex - and age-matched healthy people (without history of atherosclerotic plaque, coronary heart disease or stroke).

Case group: resting pain for at least 2 weeks with at least one hemodynamic index: ABI\<0.4,AP\<50mmHg, TP or TCPO2\<30mmHg. Tissue defects (ulceration or gangrene) persisted for at least 2 weeks with at least one significant PAD objective evidence: ABI\<0.8, AP\<100mmHg, TP or TCPO2\<60mmHg.

Exclusion Criteria

1. Patients with inflammatory bowel disease, autoimmune diseases, malignancies, infectious diseases, and severe liver and kidney dysfunction (cirrhosis, CKD stage 4 and 5).
2. Patients with thromboembolic angiitis, arterial embolism, and takayasu.
3. Patients who have used probiotics or antibiotics in the last 2 months.
4. After interventional surgery and amputation below the knee or above knee.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes